Pharma/Biotech Update: Biogen Idec’s Long Acting Drug Receives FDA Approval
March 31, 2014; Posted by: WeBleed staff
Biogen Idec’s long acting hemophilia B factor medication, Alprolix, attains long awaited approval from the Food and Drug Administration (FDA).
The wait is over.
Biogen Idec has officially received word from the U.S. Food and Drug Administration about the approval of their coagulation factor IX recombinant protein per a press release from the FDA. Biogen Idec is one of many companies currently producing long lasting factor medication pharmaceuticals for hemophiliacs. The bleeding disorders community has not seen new advancements of this magnitude in over 15 years.
Aprolix, Biogen Idec’s hemophilia B drug, will be for use in adults and children. It is the first hemophilia B treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding episodes. Alprolix consists of the “Factor IX molecule linked to a protein fragment, Fc, which is found in antibodies. This makes the product last longer in circulation.”
Says Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research: “The approval of this product provides another therapeutic option for the treatment and prevention of bleeding in patients with Hemophilia B.”
Hemophilia B affects about 3,300 people in the United States where there are repeated episodes of potentially serious bleeding. No safety concerns were identified in an earlier multi-center trial using Alprolix.
Counties outside of the United States have also approved this medication. This looks to be the start of a line of long acting hemophilia products due out to the public by the end of 2015 with Biogen Idec’s Alprolix being the beginning domino and game-changer. For those with factor IX deficiency, both as a parent and child, there is now another existing option. Stay tuned as more information and pharmaceuticals become available.
Photo Credit – Biogen Idec
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